Composition of Olivetol and Method of Use to Reduce or Inhibit the Effects of Tetrahydrocannabinol in the Human Body

ABSTRACT

Embodiments of the present invention relate to the use of a therapeutically-effective amount of Olivetol to reduce, eliminate, inhibit or alleviate the psychoactive effects of THC in users of Cannabis. Further embodiments of the present invention relate to a softgel, tablet or capsule of Olivetol in combination with an edible oil.

CROSS REFERENCE TO RELATED APPLICATIONS

The subject application is a continuation-in-part and claims priority toU.S. Provisional Patent Application Ser. No. 62/258,979, filed on Nov.23, 2015, and U.S. Non-provisional patent application Ser. No.15/360,389, filed on Nov. 23, 2016, now issued U.S. Pat. No. 9,918,947,and U.S. Non-provisional patent application Ser. No. 15/417,179, filedon Jan. 26, 2017, which applications are incorporated herein in theirentirety by this reference thereto.

TECHNICAL FIELD

The embodiments herein relate generally to use of the compound Olivetolto reduce, alleviate, or inhibit the psychoactive effects oftetrahydrocannabinol in humans or other mammals.

BACKGROUND ART

Cannabis, also commonly known as marijuana, is a flowering plant thatincludes three species or sub-species, namely sativa, indica andruderalis. The plant is indigenous to Central Asia and the IndianSubcontinent. Cannabis has long been used for hemp fiber, for oils, formedicinal purposes and as a recreational drug. Cannabis plants produce agroup of chemicals called cannabinoids. The majority of these compoundsare secreted by glandular trichromes that occur abundantly on the floralcalyxes and bracts of female Cannabis plants. When used by humansmedicinally or recreationally, Cannabis is typically consumed either byeating or smoking dried flower buds, resin, or various extracted oils orwaxes.

The most well-known cannabinoid is tetrahydrocannabinol, oftenabbreviated as “THC.” The chemical formula for THC is C₂₁H₃₀O₂ and ithas the following chemical structure:

THC is widely recognized as the principal psychoactive constituent inCannabis. However, the Cannabis plant produces hundreds of othercannabinoids, terpenoids and other compounds that are only beginning tobe identified, studied and categorized. It is believed by researchersthat many of these other cannabinoids, terpenoids and other compoundsmay have important health benefits and/or be capable of treating certainhuman diseases.

There are two characterized cannabinoid receptors in the human body,CB1, which is primarily located in the central nervous system, and CB2which is primarily located in the immune system and blood cells. Thesecannabinoid receptors are naturally present and are activated byendocannabinoids that are produced by the human body for neural and cellsignaling. In neurons, endocannabinoids bind to the CB1 receptors at thepre-synaptic junction and, among other effects, impact the release ofgamma-amino butyric acid (“GABA”). However, when THC is present in thehuman bloodstream, it binds to these cannabinoid receptors and causesmany different psychotropic effects. Consumption of Cannabis by a humangenerally results in a wide variety of psychotropic effects, which isoften referred to as a “high.” The cannabis high varies depending onmany factors, including the strain of Cannabis, the amount consumed, themethod of consumption, the biochemistry of the individual consuming itand the individual's level of experience in consuming cannabis. Thatsaid, a cannabis high can include euphoria, anxiety, a generalalteration of conscious perception, feelings of well-being, relaxationor stress reduction, increased appreciation of humor, music (especiallydiscerning its various components/instruments) or the arts, joviality,metacognition and introspection, enhanced recollection (episodicmemory), increased sensuality, increased awareness of sensation,increased libido, and creativity. Abstract or philosophical thinking,disruption of linear memory and paranoia or anxiety are also typicaleffects.

Cannabis consumption also often produces many subjective and highlytangible effects, such as greater enjoyment of food taste and aroma, anenhanced enjoyment of music and comedy, and marked distortions in theperception of time and space (where experiencing a “rush” of ideas fromthe bank of long-term memory can create the subjective impression oflong elapsed time, while a clock reveals that only a short time haspassed). Many individuals find some of these effects pleasing andenjoyable, while other individuals do not enjoy such effects.

Although Cannabis has a high margin of safety, it can produce negativeside effects. At higher doses in humans, effects can include alteredbody image, auditory and/or visual illusions, pseudo-hallucinatory, andataxia from selective impairment of polysynaptic reflexes. In somecases, in humans, cannabis can lead to dissociative states such asdepersonalization and derealization. Additionally, canine studies ofvery high doses of cannabis resulted in intoxication effects includingdepression, hypersalivation, mydriasis, hypermetria, vomiting, urinaryincontinence, tremors, hypothermia, bradycardia, nystagmus, agitation,tachypnea, ataxia hyperexcitability and seizures. Occasionally, heavyuse, or use by inexperienced human consumers, particularly in anunfamiliar environment, can result in very negative experiences. Anyepisode of acute psychosis that accompanies cannabis use usually abatesafter 6 hours, but in rare instances heavy users may find the symptomscontinuing for many days. If the episode is accompanied by aggression orsedation, physical restraint may be necessary.

No known antidote presently exists for THC overconsumption orintoxication, nor any known medications for treating cannabis dependenceor withdrawal. Efforts have been made to discover or develop such anantidote or medication, including experiments with Nabiximols,Pregnenolone, Rimonabant, and with intralipid therapy to bind to thehighly lipophilic THC, none of which have proven satisfactory. Othereffects of THC and efforts to identify antagonists to endocannabinoidreceptors are discussed in the paper, “Phytocannabinoids andEndocannabinoids,” Fišar, Zdeněk, CURRENT DRUG ABUSE REVIEWS (2009) 2,51-75, which is hereby incorporated by reference as if set forth fullyherein. Similarly, the paper “Phytocannabinoids Beyond the CannabisPlant—do they exist?” Gertsch, Jürg et al., BRITISH JOURNAL OFPHARMACOLOGY (2010) 160, 523-529, describes other compounds which mayinteract directly or indirectly with cannabinoid receptors, and which ishereby incorporated by reference as if fully set forth herein.

While many psychoactive drugs clearly fall into the category of eitherstimulant, depressant, or hallucinogen, cannabis exhibits a mix of allproperties, perhaps leaning the most towards hallucinogenic orpsychedelic properties, though with other effects quite pronounced aswell. THC is typically considered the primary active component of thecannabis plant; various scientific studies have suggested that certainother cannabinoids like CBD may also play a significant role in itspsychoactive effects.

In the early twentieth century, it became illegal in most of the worldto cultivate or possess Cannabis. However, within the last decade, somestates and nations have begun to legalize the cultivation, possessionand use of Cannabis for medical purposes. Cannabis is used to reducenausea and vomiting during chemotherapy, to improve appetite in peoplewith HIV/AIDS, to treat chronic pain, and help with muscle spasms. Otherpossible medical uses, which are sometimes disputed, include treatmentof multiple sclerosis, AIDS wasting syndrome, epilepsy, rheumatoidarthritis, glaucoma, PTSD, depression and generalized anxiety. However,many patients are hesitant to try or continue to consume cannabis due toa desire to avoid the perceived negative psychotropic effects of acannabis high. Accordingly, there is a need to address the negative,unpleasant or undesired psychotropic effects of cannabis consumption,while allowing individuals to still be able to consume it for medicalreasons and its health benefits.

Further, within the last two years, several states in the United Stateshave legalized or decriminalized the cultivation, possession and use ofCannabis for recreational purposes. As such, some sources estimate thatthere are many more recreational users of Cannabis than ever before,including new or otherwise inexperienced consumers of Cannabis. Further,with the increased availability of Cannabis, some experienced users maychoose to increase their consumption levels. Because some of theperceived negative psychotropic effects of cannabis consumption can bemore pronounced or frightening to inexperienced cannabis users, or heavycannabis users, there is a need for a way or compound that can reduce,alleviate or inhibit the psychotropic effects of cannabis after it hasbeen consumed, or after it has been consumed in a larger thanrecommended or desired amount.

Olivetol (also known as 5-pentylresorcinol or 5-pentyl-1, 3-benzenediol,5-n-Amylresorcinol, and 3,5-Dihydroxyamylbenzene) is a naturallyoccurring organic compound. The Olivetol chemical formula is C₁₁H₁₆O₂and it has the following chemical structure:

Olivetol is found in certain species of lichens and can be readilyextracted. Olivetol is also produced by a number of insects, either as apheromone, repellent, or antiseptic. The Cannabis plant internallyproduces the related substance olivetolic acid (OLA). Both Olivetol andOLA can be synthesized in the laboratory. It has been hypothesized thatthe Cannabis plant in turn utilizes OLA as a component in itsbiosynthesis of THC. Further information and explanation of Olivetol andOLA are provided in the published paper, “In Vitro And In VivoPharmacology Of Synthetic Olivetol-Or Resorcinol-Derived CannabinoidReceptor Ligands, M. G. Gascio et al., BRITISH JOURNAL OF PHARMACOLOGY(October 2006) 149(4); 431-440, which is hereby incorporated byreference as though fully set forth herein. Olivetol has beensuccessfully used as a precursor in various laboratory syntheses of THC.However, literature searches reveal no known uses of Olivetol formedicinal or other human consumption purposes.

As such, there is a need for a way or compound that can reduce,alleviate or inhibit the psychotropic effects of cannabis after it hasbeen consumed, or after it has been consumed in a larger thanrecommended amount.

SUMMARY OF INVENTION

Embodiments of the present invention relate to the use of atherapeutically-effective amount of Olivetol, and/or OLA, in some casescombined with other compounds, in various forms for delivery, to reduce,eliminate, inhibit or alleviate the psychoactive effects of THC in usersof Cannabis.

DESCRIPTION OF EMBODIMENTS

Olivetol, also known as 5-pentylresorcinol or 5-pentyl-1,3-benzenediol,is a naturally occurring compound with structures analogous to THC. Theinventors have demonstrated that consumption of Olivetol, either beforeor after consumption of THC, will significantly reduce the psychotropiceffects of THC ingestion.

It is believed that Olivetol acts as a competitive inhibitor of thecannabinoid receptors CB1 and CB2. Due to its smaller size and its lackof more functional groups, it is believed that Olivetol binds moretightly and/or more aggressively to the cannabinoid receptors CB1 and/orCB2 and has a much lower dissociation constant, allowing it to stay inthe active site of the CB receptors for a longer period of time whilenot activating the receptor, thereby not causing the change in GABArelease that is believed to be the mechanism of THC's psychotropiceffects.

Olivetol can be consumed following THC ingestion to significantly reducethe psychotropic and other effects of THC, and it is believed that itcan be consumed prior to THC ingestion, to dampen these psychotropic andother effects. The range for an effective dose of Olivetol is 8 mg to100 mg, with the preferred range between 30 mg and 60 mg. However, forcertain individuals, larger or smaller doses may be effective, ornecessary, suggesting an effective dose range of Olivetol between 4 mgto 200 mg. Further, in cases of extreme consumption of THC, even higherdoes may be advantageous. A dose approaching 10-15 mg/kg may beadvantageous.

Olivetol is a fat soluble compound that should be combined with andconsumed with a human-consumable fatty oil for best absorption in thegastrointestinal tract including in the stomach and small intestine. Anyedible oil in which the Olivetol molecule will dissolve will suffice. Inone embodiment, Olivetol is mixed with and/or dissolved in olive oil.However other edible oils are suitable, including major food oils suchas vegetable, canola, peanut, almond, coconut, avocado, sesame, corn,cottonseed, palm, safflower, rapeseed, soybean, and sunflower; nut oilssuch as almond, beech nut, brazil nut, cashew, hazelnut, macadamia,mongongo nut, pecan, pine nut, pistachio, and walnut; citrus oils suchas grapefruit seed oil, lemon oil, and orange oil; oils from melon andgourd seeds including from the members of the Cucurbitaceae family, suchas bitter gourd oil, bottle gourd oil, buffalo gourd oil, butternutsquash seed oil, egusi seed oil (from Cucumeropsis mannii naudin seeds),pumpkin seed oil and watermelon seed oil; food supplement oils such asAçaí oil (from fruit of several species of the Açaí palm), black seedoil (pressed from Nigella sativa seeds), blackcurrant seed oil (fromRibes nigrum seeds), borage seed oil (from Borago officinalis seeds),evening primrose oil (from Oenothera biennis seeds), and flaxseed oil(or linseed oil)(from Linum usitatissimum seed); or other known edibleoils such as amaranth seed oil (from sees of grain amaranth speciesincluding Amaranthus cruentus and Amaranthus hypochondriacus), apricotoil, apple seed oil, argan oil (from the seeds of the Argania spinosa),artichoke, avocado, babassu oil (from the seeds of the Attaleaspeciosa), ben oil (from the seeds of Moringa oleifera), Borneo tallownut oil (extracted from the fruit of species of genus Shorea), capechestnut oil (also called yangu oil), carob pod oil (Algaroba oil),cocoa butter, cocklebur oil (from species of genus Xanthium), cohune oil(from Attalea cohune), coriander seed, date seed oil, dika oil (fromIrvingia gabonensis seeds), false flax oil (from Camelina sativa seeds),grape seed oil, hemp oil, kapok seed oil (from Cieba pentandra seeds),kenaf seed oil (from Hibiscus cannabinus seeds), lallemantia oil (fromLallemantia iberica seeds), mafura oil (from Trichilia emetica seeds),marula oil (from Sclerocarya birrea kernel), meadowfoam seed oil,mustard oil, niger seed oil (including from Guizotia abyssinica), nutmegbutter (extracted by expression form the fruit of cogeners of genusMyristica), nutmeg oil, okra seed oil (from Abelmoschus esculentusseeds), papaya seed oil, papaya oil produced by maceration, perilla seedoil, persimmon seed oil (including from Diospyros virginiana), pequi oil(from Caryocar basiliense seeds), pili nut oil (from Canarium ovatumseeds), pomegranate seed oil (from Punica granatum seeds), poppy seedoil, pracaxi oil (from Pentaclethra macroloba seeds), prune kernel oil,peach kernel oil, quinoa oil, ramtil oil (from one of several species ofgenus Guizotia abyssinica seeds), rice bran oil, royle oil (fromPrinsepia utilis seeds), sacha inchi oil, sapote oil, seje oil (fromJessenia bataua seeds), shea butter, taramira oil (from arugula or Erucasativa seeds), tea seed oil (camelia oil), thistle oil (from Silybummarianum seeds), Tigernut oil (or nut-sedge oil, from the Cyperusesculentus tuber), tobacco seed oil (from Nicotiana species seeds, ifpurified), tomato seed oil, and wheat germ oil. It will be understoodthat the above list is exemplary, and not meant to be limiting.

The effects of Olivetol on a person who has ingested THC will includebut are not limited to clarity of mind, improved vision, increasedability to focus, improved motor skills, and reduction in any othersymptoms of THC consumption.

A number of real-life, non-clinical trials have been performed byvolunteers, to test the effects of the consumption of embodiments of thepresent invention, the conditions and results of which are described asfollows. All tests were performed in “real life,” rather than clinicalconditions. Various methods of consumption of cannabis were used, suchas consumption of edibles, inhalation of cannabis smoke, or inhalationof vapor, depending upon the volunteer's preference. Some subjectsreported their pre-consumption mood, pain level, etc., as well as theirlevel of experience with consumption of cannabis. After sufficientexposure to cannabis, each subject indicated when their euphoria or“high” had reached a high level or a peak. Then, the subject took one ormore oral doses of an embodiment of the present invention, containing 30mg of Olivetol combined with edible oil in a “softgel” pill. A timer wasstarted and the subject then reported when they felt an awareness of adecrease or reduction in their euphoria or other cannabis effects, aswell as their subjective feelings, mood, pain level or otherobservations, until they self-reported that their cannabis effects wereconcluded. In the majority of cases, subjects noticed a reduction in theeffects of cannabis consumption between four to ten minutes, and mostcommonly six to seven minutes, after taking a dose of an embodiment ofthe present invention. Most subjects reported some improved level ofmental clarity. However, most subjects also reported that the beneficialeffects of their cannabis consumption, such as improved mood or painreduction, remained even after the euphoric feeling and other physicaleffects associated with cannabis use declined following their use of adose or two of an embodiment of the present invention.

In a first set of informal testing, volunteer testers provided thefollowing information about their experiences, which were set forth inthe attachments to the provisional patent application to which thisapplication claims priority and which are summarized as follows:

Example 1A

Subject JS, inhaled cannabis smoke, from the strain “Kush.” At the timeof initial exposure to cannabis, subject had a mild headache, wasslightly melancholy, and a bit tired. Thirty minutes after inhalation ofcannabis smoke, subject reported mild euphoria and a loss ofcoordination and balance. At forty-five minutes after inhalation ofcannabis smoke, subject reported subject's high had peaked, subject waseuphoric, and subject's headache was resolved. At this peak of the high,the subject took one softgel of an embodiment of the present invention.Within ten minutes after the dose, subjected reported an awareness of areduction in subject's high. Subject noted “head clears, body stillunstable.” Within thirty minutes after the dose, subject reportedsubject had returned to initial status, but that subject had “noheadache, no melancholy, no change in energy.” At one hour and fifteenminutes after the dose, subject reported that subject's high began toreturn and reported “loss of balance, coordination, mild euphoria.” Atthat time, subject took a second capsule of an embodiment of the presentinvention. Within fifteen minutes after the second dose, subjectreported that subject's high began to decline, and that “head clears,body still unstable.” Within thirty minutes of the second dose, subjectreported that subject had returned to initial status and “body returnsto function.”

Example 1B

Subject KD, inhaled cannabis smoke, from the strain “GS Cookies” as wellas “Kief.” Subject self-reported as an occasional consumer of cannabis.At the time of initial exposure to cannabis, subject reported thatsubject was “calm, balanced.” Within two minutes after inhalation ofcannabis smoke, subject reported onset of a cannabis high and noted thatsubject's heartbeat and pulse were increased. Seven minutes afterinhalation of cannabis smoke, subject reported a peak cannabis high andtook a first softgel of an embodiment of the present invention, for adose of 30 mg of Olivetol. Within nine minutes after the dose, subjectedreported an awareness of a reduction in subject's high. Subject noted“heartbeat quiets.” Within seventeen minutes after the dose, subjectreported subject had returned to initial status and that subject wasthirsty. Within thirty-eight minutes after the dose, subject reportedthat subject's high began to return. Within fifty-five minutes after thedose, however; subject reported that subject's high began to declineagain. Within approximately seventy-six minutes after the dose, subjectreported that subject had returned to initial status and was “ok todrive.” At one-hundred and six minutes after the dose, the subjectreported “ready to leave.”

Example 1C

Subject JM, inhaled cannabis smoke, from the strain “GS Cookies” as wellas “Kief.” At the time of initial exposure to cannabis, subject was“relaxed,” “not high” and reported having consumed a full mealapproximately two hours earlier. Five minutes after inhalation ofcannabis smoke, subject reported the beginning of a cannabis high andthat subject felt “euphoria, relaxation, mind high, dry mouth, eyes.”Fourteen minutes after inhalation of cannabis smoke, subject reported,subject reported subject's high had peaked, and noted that “laser lightcat play distracting.” At this peak of the high, the subject took onesoftgel of an embodiment of the present invention, for a dose of 30 mgof Olivetol. Within six minutes after the dose, subjected reported anawareness of a reduction in subject's high. Subject noted “lessening offrontal brain euphoria” and “eyes watering slightly.” Within thirty-twominutes after the dose, subject reported that subject had returned toinitial status.

In a second set of informal testing, volunteer testers provided thefollowing information about their experiences.

Example 2A

Subject CH, who had had no food within the preceding two hours, had notconsumed alcohol in the previous eight hours, who was on no othermedications, and who gotten acceptable but not adequate sleep the nightbefore (“so-so”), and who was self-described as a social consumer ofcannabis, reported an overall feeling of 8.5 out of 10, a good mood, notension, but a little pain in subject's foot. Subject consumed asufficient amount of cannabis to self-describe as feeling a cannabishigh, which subject rated as a level of 9 out of a possible 10. Subjectdescribed feeling “giddy, dehydrated, tingly, hyper focused, dissociatedand creative.” Subject reported no pain, that subject's body felt good,a good mood, a little fogginess, and no paranoia, anxiety or tension.Subject was “not sure” about subject's ability to solve a complexproblem, and indicated subject's ability to handle an emergency was“so-so.” Subject took a dose of one softgel of an embodiment of theinvention described herein. Within three minutes, subject described anawareness of a reduction in subject's high. Subject further describedthat at ten minutes after taking the dose, the subject felt “about ¾normal.” Subject further described that at eighteen minutes after takingthe dose, the subject reported a level of high at 1.5 out of a possible10, that subject's body felt good, without pain, with no fogginess, anda serious but relaxed mood. The subject indicated that subject's abilityto solve a complex problem was “better” and that subject's ability tohandle an emergency was “good.” At eighteen minutes and forty-fiveseconds after taking the dose, the subject reported the subject was“back to normal.” At forty-three minutes after taking the dose, thesubject reported “I'm thinking super sharp.”

Example 2B

Subject DO, who not eaten within the preceding two hours, had notconsumed alcohol in the previous eight hours, who was on no othermedications, and who got adequate sleep the night before, and who didnot report frequency of cannabis use, reported mild pain in thesubject's joints, tension in subject's neck, and a mood of sadness.Subject consumed a sufficient amount of cannabis to self-describe asfeeling a cannabis high, which subject rated as a level of 9 out of apossible 10. Subject described subject's feeling as “comfortable,”“chill” and “relaxed.” Subject described subject's body feeling as a 9,a slight fogginess, a very relaxed mood, and little paranoia, anxiety ortension. Subject described subject's ability to solve a complex problemas an 8 out of 10, but subject's ability to respond to an emergency as a4 out of 10. Subject took a dose of one softgel of an embodiment of theinvention described herein. Within ten minutes, subject described anawareness of a reduction in subject's high. At about thirty minutesafter taking the dose, subject reported a level of high of 4.5 out of10, rated the feeling of subject's body as a 9 out of 10, a fogginess of3 out of 10, a mood as an 8 or 9 out of ten, an ability to solve acomplex problem as 9 out of 10 and an ability to handle an emergency asa 6 or 7 out of 10.

Example 2C

Subject LS, who had had a meal within the preceding two hours, had notconsumed alcohol in the previous eight hours, who was on an unspecifiedmedication, and who got adequate sleep the night before, and who wasself-described as a consumer of cannabis for pain relief and relaxation,reported a high level of pain in the subject's lower back, no tension insubject's body and an overall mood and feeling of “ok” and “10.” Subjectconsumed a sufficient amount of cannabis to self-describe as feeling acannabis high, which subject rated as a level of 10 out of a possible10. Subject described feeling “relaxed,” “happy” and “energized.”Subject reported a significant lessening of pain, a “great” mood, noparanoia, anxiety or tension, but a level of fogginess of 7 out of 10.The subject reported subject's ability to solve a complex problem as a 7out of 10 and subject's ability to handle an emergency as 10 out of 10.Subject took a dose of one softgel of an embodiment of the inventiondescribed herein. Within ten minutes, subject described an awareness ofa reduction in subject's high. At about thirty minutes after taking thedose, subject reported a level of high of 3 out of 10, rated the feelingof subject's body 10 of 10, meaning no pain, a fogginess of 5 out of 10,a mood as 10 out of 10, an ability to solve a complex problem as 10 outof 10 and an ability to handle an emergency as a 10 out of 10. Subjectalso described subject's feeling as “relaxed” and “really chill.”

Example 2D

Subject MB, who had not eaten within the preceding two hours, had notconsumed alcohol in the previous eight hours, who was on an unspecifiedmedication, and who got adequate sleep the night before, and who wasself-described as a consumer of cannabis for the purpose of experiencingthe high that it induces, reported having no pain, and an overall moodand feeling of 9 out of 10. Subject consumed a sufficient amount ofcannabis to self-describe as feeling a cannabis high, which subjectrated as a level of 9 out of a possible 10. Subject described feeling“great.” Subject reported no pain, a mood of 10 out of 10, a slightfeeling of paranoia, anxiety or tension, and a level of fogginess of 6out of 10. The subject reported subject's ability to solve a complexproblem as a 5 out of 10 and subject's ability to handle an emergency as3 out of 10. Subject took a dose of one softgel of an embodiment of theinvention described herein. Within thirteen minutes, subject describedan awareness of a reduction in subject's high. At about thirty minutesafter taking the dose, subject reported a level of high of 3 out of 10,stated that the feeling of subject's body was “slow/fine,” a fogginessof 2 out of 10, a mood as 10 out of 10, an ability to solve a complexproblem as 9 or 10 out of 10 and an ability to handle an emergency as a1 to 3 out of 10. Subject also described his feeling as “smiling,”“happy,” and “loose.” Subject noted that subject took a second capsuleapproximately an hour and nine minutes after the first. Subject notedthat at an hour and thirty-five minutes after the first capsule, subjectwas “still not clear.”

In a third set of informal testing, volunteer testers provided thefollowing information about their experiences.

Example 3A

Subject Cris, who had had a light meal within the preceding two hours,had not consumed alcohol in the previous eight hours, who was on noother medications, and who got adequate sleep the night before, and whowas self-described as a frequent consumer of cannabis for purposes ofsleep, upset stomach and seeking a cannabis high, reported mild tomoderate pain and tension in subject's body. Subject consumed asufficient amount of cannabis to self-describe as feeling a cannabishigh, which subject rated as a level of 6 out of a possible 10. Subjectdescribed subject's experience as doing little to alleviate subject'spain, creating a significant level of “fogginess”, having very littleability to solve a complex problem, very little ability to respond to anemergency situation, slightly uncomfortable, somewhat tired, and someamount of paranoia. Subject took a dose of one softgel of an embodimentof the invention described herein. Within six minutes, subject describedan awareness of a reduction in subject's high. Subject further describedthat subject's paranoia was “going away,” that subject felt“comfortable,” “fine,” “happy” and “ok,” and that subject still felt“loose.” By twenty-four minutes after taking the embodiment of thepresent invention, subject reported that he no longer felt tired.

Example 3B

Subject SAL, who had no food within the preceding two hours, had notconsumed alcohol in the previous eight hours, who was on no othermedications, and who got adequate sleep the night before, and who wasself-described as a daily consumer of cannabis for purposes ofrecreation and relaxation, reported mild pain and tension in subject'sbody. Subject consumed a sufficient amount of cannabis to self-describeas feeling a cannabis high, which subject reported as a level of 7 outof a possible 10. Subject described subject's level of pain or tensionas mild, and moderate level of “fogginess.” Subject also self-describedsubject's ability to solve a complex problem or respond to an emergencyas very high. Subject also self-described subject's feeling as“relaxed,” “calm,” “confident,” and “funny,” but noted the sensationthat “legs sometimes disappear.” Subject took a dose of one softgel ofan embodiment of the invention described herein. Within fifteen minutes,subject described an awareness of a reduction in subject's high. Subjectfurther described slight sadness that the high was over.

Example 3C

Subject KL who had had a meal within the preceding two hours, hadconsumed one alcoholic beverage in the previous eight hours, who was onno other medications, and who got adequate sleep the night before, andwho was self-described as consuming cannabis approximately twice amonth, reported a good mood and moderate pain in subject's toe. Subjectconsumed a sufficient amount of cannabis to self-describe as feeling acannabis high, which subject reported as a level of 8 out of a possible10. Subject described subject's level of pain or tension as low, andmoderate level of “fogginess.” Subject also self-described subject'sability to solve a complex problem as moderate, and subject's ability torespond to an emergency as low. Subject also self-described subject'sfeeling as “feel like laughing,” “releases the mind,” and “fuzzy.”Subject took a dose of one softgel of an embodiment of the inventiondescribed herein. Within seven minutes, subject described an awarenessof a reduction in subject's high. Subject further described a decreasein the level of “fogginess” and a feeling of “lots of clarity” and anability to follow complex conversations.

Example 3D

Subject WL who had had a meal within the preceding two hours, hadconsumed three sips of an alcoholic beverage in the previous eighthours, who was on statin medication for blood pressure and thyroidissues, and who got adequate sleep the night before, and who wasself-described as consuming cannabis in the amount of “2-3 hits” daily,for purposes of relaxation, reported a moderate mood and moderate pain,but high levels of tension in the body. Subject consumed a sufficientamount of cannabis to self-describe as feeling a cannabis high, whichsubject reported as a level of 9 out of a possible 10. Subject describedsubject's level mood as excellent, pain and tension as essentiallyunchanged, and high level of “fogginess.” Subject also self-describedsubject's ability to solve a complex problem as high, and subject'sability to respond to an emergency as very high. Subject took a dose ofone softgel of an embodiment of the invention described herein. Withinfive minutes, subject described an awareness of a reduction in subject'shigh. Subject further described feeling of being “clear” and“energized.”

Example 3E

Subject Hamed who had had a meal within the preceding two hours, had notconsumed alcohol in the previous eight hours, who was on no othermedications, and who got adequate sleep the night before, and who wasself-described as consuming cannabis three to four times per week,reported feeling “stressed” and having tension in subject's upper andlower body, but no pain. Subject consumed a sufficient amount ofcannabis to self-describe as feeling a cannabis high, which subjectreported as a level of 9 out of a possible 10. Subject describedsubject's level of tension lessened, and high level of “fogginess.”Subject also self-described subject's ability to solve a complex problemas low, and subject's ability to respond to an emergency as low. Subjectalso self-described subject's feeling as “relaxed” and “very” high.Subject took a dose of one softgel of an embodiment of the inventiondescribed herein. Within twenty-four minutes, subject described anawareness of a reduction in subject's high. Subject further described adecrease in the level of “fogginess” to low, no pain, little to notension in subject's body and an increase in subject's ability toperform complex tasks or respond to an emergency to a moderate level.

Example 3F

Subject Leah who had not had a meal within the preceding two hours, hadnot consumed alcohol in the previous eight hours, who was on no othermedications, who did not have adequate sleep the night before, and whodid not report the frequency of her cannabis consumption, but did reportconsuming cannabis for purposes of relaxation, reported a good mood,some pain in her right hip, and neck and shoulder tension. Subjectconsumed a sufficient amount of cannabis to self-describe as feeling acannabis high, which subject reported as a level of 11.5 out of apossible 10. Subject described subject's level of pain and tension asnonexistent, and reported feeling “tipsy,” but also reported anxiety andrapid breathing. Subject also self-described her high as “Life feelslike I need to recover from it.” Subject took a dose of one softgel ofan embodiment of the invention described herein. Within three minutes,subject described an awareness of a reduction in subject's high. Subjectfurther described that she “was tipsy—now centering.”

Example 3G

Subject ID who had not had a meal within the preceding two hours, hadnot consumed alcohol in the previous eight hours, who was on no othermedications, and who got adequate sleep the night before, and who wasself-described as consuming cannabis frequently, reported a moderatelygood mood. Subject consumed a sufficient amount of cannabis toself-describe as feeling a cannabis high, which subject reported as alevel of 9 out of a possible 10. Subject described subject's level ofpain or tension as low, and a low level of “fogginess.” Subject alsoself-described subject's ability to solve a complex problem as moderate,and subject's ability to respond to an emergency as high. Subject alsoself-described subject's feeling as “like I am floating,” and alsoreported a tingling sensation. Subject took a dose of one softgel of anembodiment of the invention described herein. Within four minutes,subject described an awareness of a reduction in subject's high. Subjectfurther described an increase in subject's ability to solve a complexproblem and that “I am feeling really nice right now.”

Example 3H

Subject MW who had not had a meal within the preceding two hours, hadconsumed one alcoholic beverage in the previous eight hours, who was onno other medications, and who got adequate sleep the night before, andwho was self-described as consuming cannabis that had a low level of THCand a high level of CBD (although frequency of use was not reported),reported a good mood and low level of pain or tension in subject's body.Subject consumed a sufficient amount of cannabis to self-describe asfeeling a cannabis high, which subject reported as a level of 7 out of apossible 10. Subject described subject's level of pain or tension aslow, and moderate level of “fogginess.” Subject also self-describedsubject's ability to solve a complex problem as moderate, and subject'sability to respond to an emergency as moderate. Subject alsoself-described subject's feeling as “high” and that it was a “headhigh-detached.”Subject took a dose of one softgel of an embodiment ofthe invention described herein. Subject described an awareness of areduction in subject's high, but did not report the time at which thatawareness occurred. Subject further described a slight increase in thelevel of “fogginess” and an increase in the ability to solve complexproblems or respond to an emergency. The subject also reported that“body is very relaxed, and no head high.”

Example 3I

Subject S who had had a meal within the preceding two hours, hadconsumed one alcoholic beverage in the previous eight hours, who was onno other medications, and who got adequate sleep the night before, andwho was self-described as consuming cannabis approximately twice amonth, reported a good mood and moderate pain in subject's toe. Subjectconsumed a sufficient amount of cannabis to self-describe as feeling acannabis high, which subject reported as a level of 8 out of a possible10. Subject described subject's level of pain or tension as low, andmoderate level of “fogginess.” Subject also self-described subject'sability to solve a complex problem as moderate, and subject's ability torespond to an emergency as low. Subject also self-described subject'sfeeling as “feel like laughing,” “releases the mind,” and “fuzzy.”Subject took a dose of one softgel of an embodiment of the inventiondescribed herein. Within seven minutes, subject described an awarenessof a reduction in subject's high. Subject further described a decreasein the level of “fogginess” and a feeling of “lots of clarity” and anability to follow complex conversations.

One embodiment of the present invention for administration of atherapeutically effective amount of Olivetol comprises one softgel,containing the following formulation:

30 mg Olivetol

750 mg Olive oil

10 mg Vitamin E

A dose may be considered either 1 or 2 capsules, as needed. In oneembodiment, the oil and Olivetol formulation is encapsulated ingelatin-based “softgel” capsules. In another embodiment, the dose isformulated in a vegetable-based capsule so that it may be taken byvegetarians. Other embodiments include a combination of atherapeutically effective dose of Olivetol, combined with an edible oil,in a capsule, such as a hard shell capsule, a soft gel capsule, a capletor a tablet. Embodiments of the invention may include an oil solubleanti-oxidant. Such an antioxidant is useful for preserving theshelf-life of the oil, particularly oils listed above that may spoil orgo rancid when stored at room temperature.

For alternative embodiments, it would be suitable to use any oil that isliquid at room temperature, with the preferred oils having the longestshelf life. Vitamin E is a powerful, fat-soluble antioxidant included toreduce oxidation over time, thereby increasing shelf life. Foralternative commercial embodiments, other suitable fat-solubleantioxidants may be used. A non-limiting list of such alternative fatsoluble antioxidants includes Vitamin A, Carotenes, Lutein, Lycopene,Cryptoxanthin, lipoic acid, and known substitutes for each.

Alternative embodiments of the present invention for administration of atherapeutically effective amount of Olivetol comprise one softgel,containing one or more of the following formulations. For each suchformulation, additional known or anticipated beneficial health effectsare stated:

(a) Olivetol—50 mg

-   -   Lecithin—50 mg    -   Olive oil—700 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Extra strength, rapid relief, good        for cholesterol control.

(b) Olivetol—40 mg

-   -   Coconut oil—200 mg    -   Olive oil—550 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Antioxidant, good for cholesterol        control.

(c) Olivetol—30 mg

-   -   Coconut oil—200 mg    -   Avocado oil—550 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Anti-inflammatory, heart healthy.

(d) Olivetol—40 mg

-   -   Avocado oil—200 mg    -   Olive oil—550 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Anti-oxidant, anti-inflammatory,        good for cholesterol control.

(e) Olivetol—30 mg

-   -   Sesame oil—150 mg    -   Macadamia oil—50 mg    -   Avocado oil—550 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Anti-oxidant, anti-inflammatory,        energy boosting.

(f) Olivetol—50 mg

-   -   Coconut oil—250 mg    -   Macadamia oil—250 mg    -   Avocado oil—250 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Energy boosting, immune system        boosting, heart healthy.

(g) Olivetol—40 mg

-   -   Almond oil—200 mg    -   Coconut oil—400 mg    -   Sesame oil—150 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Anti-oxidant, anti-inflammatory,        anti-bacterial.

(h) Olivetol—30 mg

-   -   Avocado oil—200 mg    -   Hemp seed oil—400 mg    -   Pumpkin oil—150 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Anti-oxidant, anti-inflammatory,        anti-diabetic effects, heart healthy.

(i) Olivetol—40 mg

-   -   Avocado oil—250 mg    -   Hemp seed oil—250 mg    -   Coconut oil—250 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Heart healthy, supports the immune        system, anti-bacterial.

(j) Olivetol—30 mg

-   -   Avocado oil—200 mg    -   Hemp seed oil—200 mg    -   Olive oil—350 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Heart healthy, supports immune        system, good for cholesterol control.

(k) Olivetol—40 mg

-   -   Almond oil—100 mg    -   Hemp seed oil—200 mg    -   Coconut oil—200 mg    -   Olive oil—250 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Anti-oxidant, supports immune        system, heart healthy, good for cholesterol control.

(l) Olivetol—40 mg

-   -   Sesame oil—150 mg    -   Almond oil—200 mg    -   Macadamia oil—200 mg    -   Avocado oil—200 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Anti-inflammatory, heart healthy.

(m) Olivetol—50 mg

-   -   Almond oil—300 mg    -   Avocado oil—300 mg    -   Poppy seed oil—50 mg    -   Macadamia oil—100 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Heart healthy, calming,        anti-inflammatory.

(n) Olivetol—40 mg

-   -   Olive oil—200 mg    -   Acai oil—50 mg    -   Blackcurrant oil—50 mg    -   Almond oil—450 mg    -   Vitamin E—10 mg    -   Health Effects or Benefits: Heart healthy, anti-oxidant.

(o) Olivetol—30 mg

-   -   Almond oil—150 mg    -   Macadamia oil—150 mg    -   Walnut oil—150 mg    -   Pistachio oil—150 mg    -   Sesame oil—150 mg    -   Health Effects or Benefits: Heart healthy, anti-bacterial.

(p) Olivetol—40 mg

-   -   Sesame oil—50 mg    -   Olive oil—200 mg    -   Avocado oil—100 mg    -   Macadamia oil—200 mg    -   Artichoke oil—200 mg    -   Health Effects or Benefits: Heart healthy.

In other embodiments of the invention, other nutraceuticals, vitamins,minerals, herbs herbal extracts, or essential oils may be added to thecombination of Olivetol and edible oil, in order to promote or providecertain nutrients, minerals, supplement effects or health benefits, inaddition to the effects of the Olivetol and edible oil combinationdescribed herein.

In embodiments of the invention, preferably, the Olivetol is between97-98% pure. However, lower purity may be acceptable, particularly ifthe amount used per dose is increased.

An alternative embodiment for a method of delivery of Olivetol isthrough the use of liposomal delivery. A liposome is a spherical vesiclehaving at least one lipid bilayer. The liposome can be used as a vehiclefor administration of nutrients and pharmaceutical drugs. Liposomes canbe prepared by disrupting biological membranes (such as by sonication).Liposomes are most often composed of phospholipids, especiallyphosphatidylcholine, but may also include other lipids, such as eggphosphatidylethanolamine, so long as they are compatible with the lipidbilayer structure.

In some embodiments, Olivetol may be included in liposomes made fromphospholipids. These encapsulating phospholipids containing Olivetol,when delivered orally/sublingually or intravenously, bond with cellmembranes to facilitate intracellular delivery. Liposomes may be formedfrom lecithin, or high-phosphatidylcholine phospholipid mixes, as willbe appreciated by one of skill in the art. Further, phospholipidparticle size may vary according to different embodiments, ranging from50 nm to 600 nm, but more preferably ranging from 50 nm to 100 nm.Embodiments of this delivery method of the present invention may besuspended in a suitable carrier (such as an aqueous solution or atincture), and either sprayed into the subject's mouth, or injectedintravenously.

Additional embodiments of the present invention include the addition offlavorings or flavor blockers, addition of the Olivetol to an oil-basedcandy or edible, or other suitable delivery methods for oil-basednutraceuticals, including as an edible oil/Olivetol combination to beadministered orally by drinking.

Preferably, the Olivetol used in the present invention should not beheated prior to use and should be stored at room temperature or cooler.

While a dose of between 4 mg-200 mg is therapeutically effective formost persons, in certain circumstances it may be desirable to deliverhigher dosages. In particular, when a person has consumed an extremeamount of THC, or is suffering from anxiety, panic, or is experiencing apsychotic episode, it may be advisable to administer an oral dose ofpurified Olivetol of as much as 10-15 milligrams per kilogram of bodyweight. Thus, for an average person, based on an estimated averageweight in North America of approximately 80 kg, a higher dose mayapproach 800-1000 mg. Ranges of high dosages that may be beneficial,include, without limitation, 200 mg-1000 mg, 200 mg-800 mg, 200 mg-600mg, 200 mg-400 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, 500 mg, 550mg, 600 mg, 650 mg, 700 mg, 750 mg, 800 mg, 850 mg, 900 mg, 950 mg, 1000mg, and all dosages within these ranges, depending upon the person'sresponse, or lack thereof, to lower dosages.

Although specific embodiments of the invention have been disclosed,those having ordinary skill in the art will understand that changes canbe made to the specific embodiments without departing from the spiritand scope of the invention. The scope of the invention is not to berestricted, therefore, to the specific embodiments disclosed.

What is claimed is:
 1. A method of reducing the psychoactive effects ofTHC in humans comprising the step of orally administering atherapeutically-effective dose of Olivetol, before or after consumptionof THC, wherein said dose is between 200 mg and 1000 mg.
 2. The methodof claim 1, wherein said dose is between 200 mg and 800 mg.
 3. Themethod of claim 1, wherein said dose is between 200 mg and 700 mg. 4.The method of claim 1, wherein said dose is between 200 mg and 600 mg.5. The method of claim 1, wherein said dose is between 200 mg and 500mg.
 6. The method of claim 1, wherein said dose is between 200 mg and400 mg.
 7. The method of claim 1, wherein said dose is 200 mg.
 8. Themethod of claim 1, wherein said dose is 250 mg.
 9. The method of claim1, wherein said dose is 300 mg.
 10. The method of claim 1, wherein saiddose is 350 mg.
 11. The method of claim 1, wherein said dose is 400 mg.12. The method of claim 1, wherein said dose is 500 mg.
 13. The methodof claim 1, wherein said dose is 600 mg.
 14. The method of claim 1,wherein the dose is 700 mg.
 15. The method of claim 1, wherein the doseis 800 mg.
 16. The method of claim 1 wherein the step of orallyadministering comprises administering a softgel containing thetherapeutically-effective dose of Olivetol.
 17. The method of claim 16wherein the softgel further comprises an edible oil.
 18. The method ofclaim 17 wherein the softgel further comprises an anti-oxidant.
 19. Themethod of claim 18 wherein the anti-oxidant comprises Vitamin E.
 20. Themethod of claim 1 wherein the step of orally administering comprisesadministering a plurality of softgels, which in combination, contain thetherapeutically-effective dose of Olivetol.